Informational Medical Device Registration Process in Brazil - Anvisa (Part 3)

maya_tanase · Dec 4, 2018

Hi Marcelo,

Thank you so much for the information already shared in this thread.

However, it is still not clear to me whether a foreign manufacturer can have simultaneously more than one BRHs for the same medical device.
For instance could (a) an agency and a distributor or (b) multiple distributors act as BRHs at the same time?
If this is the case, the same medical device would have to be registered multiple times (thus each BRH would be in possession of their own registration number).
Is this scenario realistic?

Thank you.
Best regards,
Maya

Marcelo · Dec 4, 2018

maya_tanase said:
Hi Marcelo,

Thank you so much for the information already shared in this thread.

However, it is still not clear to me whether a foreign manufacturer can have simultaneously more than one BRHs for the same medical device.
For instance could (a) an agency and a distributor or (b) multiple distributors act as BRHs at the same time?
If this is the case, the same medical device would have to be registered multiple times (thus each BRH would be in possession of their own registration number).
Is this scenario realistic?

Thank you.
Best regards,
Maya

Only if you are changing the BHR. It's not expected that a device have more than one BHR, but this could happen when you are changing. Another easier solution is to have one BHR such as a consulting firm that deals to Import License for whoever you want.

maya_tanase · Dec 4, 2018

Marcelo Antunes said:
Only if you are changing the BHR. It's not expected that a device have more than one BHR, but this could happen when you are changing. Another easier solution is to have one BHR such as a consulting firm that deals to Import License for whoever you want.

Thank you so much for your quick reply, it really made the difference.
I was also interested in understanding what would happen if the current BRH does not consent to the licence transfer to a new entity (either an agency or another importer/distributor).
Does the manufacturer have to wait for the device registration (with the old BRH) to expire or could they start a new registration (with a new BRH) right away?

Thank you,
Best regards,
Maya

Marcelo · Dec 4, 2018

maya_tanase said:
Thank you so much for your quick reply, it really made the difference.
I was also interested in understanding what would happen if the current BRH does not consent to the licence transfer to a new entity (either an agency or another importer/distributor).
Does the manufacturer have to wait for the device registration (with the old BRH) to expire or could they start a new registration (with a new BRH) right away?

Thank you,
Best regards,
Maya

They can start a new registration right away.

cos_reg · Feb 28, 2019

Dear all, I don't know if this topic has already been addressed. Where is it possible to find the whole list of medical devices that require the Inmetro Certification? I am asking this in order to correctly register in Brasil a class II active medical device.

If yes, it is needed to partner with laboratories such as UL or it can be done directly with Inmetro? I am based in Europe and the device is already CE marked

Thank you very much

Marcelo · Feb 28, 2019

cos_reg said:
Dear all, I don't know if this topic has already been addressed. Where is it possible to find the whole list of medical devices that require the Inmetro Certification? I am asking this in order to correctly register in Brasil a class II active medical device.

Here Regulamentos Técnicos e Programas de Avaliação da Conformidade compulss - Qualidade - Inmetro. Search in column "Órgão Regulamentador" for ANVISA.

If yes, it is needed to partner with laboratories such as UL or it can be done directly with Inmetro? I am based in Europe and the device is already CE marked

You can perform testing abroad (as long as the the testing house and test reports fulfills certain requirements), but the process is done in Brazil by Brazilian certification bodies.

cos_reg · Feb 28, 2019

Thank you! Where is it possibile to find a list of brazilian certification bodies? They will also require documentation such as, for example, software and usability documentation?

Marcelo · Feb 28, 2019

cos_reg said:
Thank you! Where is it possibile to find a list of brazilian certification bodies?

Here: Organismos Acreditados . You need to chose "Certificação de Produtos - OCP"and the look into each one to see if they are accredited to the scope you require.

They will also require documentation such as, for example, software and usability documentation?

if it's a medical electrical equipment under portaria 54, yes, they verify compliance with IEC 60601, all collateral and particular standards, and related standards such as ISO 14971 and IEC 62304.

apuigvert · Mar 19, 2019

Hello all, have any of you analyzed the new RDC 270/2019? from Article 1, I understand that it is applicable to class I and IVDs. But then below it mentions Class I and II. Also, I am not sure what exactly is modifying in the process, it seems to be the same but with a limited timeframe of 30 days for the approval. Any help is welcome! Thanks!

Marcelo · Mar 21, 2019

RDC 270 changes the registration process for class I devices to a notification process, so after it begins enforcement, to put a class I device into the market in Brazil, you only need to ask ANVISA for a notification number, they will give you the number in 30 days and then you can put the device into market.

Informational Medical Device Registration Process in Brazil - Anvisa (Part 3)

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